Obesity is a condition that affects millions of Americans. Recent statistics show that when obesity is defined as a 20% excess over desirable weight, 20-30% of adult men and 30-40% of adult women are obese. Even mild obesity increases the risk for premature death, diabetes, hypertension, atherosclerosis, gallbladder disease, and even some forms of cancer (Olefsky, J. M. 1994, Harrison's Principles of Internal Medicine, 446-452). Therefore, effective methods for weight reduction are constantly being sought.
Although there are many different treatment regimens in use today that can produce a short term or temporary weight loss, most are associated with a rapid increase in weight once treatment is terminated. Caloric restriction is the main goal of most weight reduction treatment regimens. The basic principle is that if intake of food is less than energy expenditure, stored calories will be consumed, mainly in the form of fat. However, once the diet regimen is broken, weight is quickly regained.
Other treatment regimens are based on the principle of increasing metabolism. By increasing metabolism, calories are burned thereby decreasing body weight. However, these treatments often have side effects, particularly those involving use of non-prescription and prescription drug products. Further, these treatments also often result in rapid weight increases once treatment is terminated, unless modification of behavior that led to weight gain is undertaken. In the case of nutritional supplement regimens, poor taste is often a problem despite addition of taste-improving substances to the product.
Weight reduction has also been attempted using surgical intervention wherein the size of the stomach is reduced so that a feeling of gastric fullness is produced, resulting in a decrease in appetite and food intake. One such method is placement of a mechanical device such as an inflatable balloon into the stomach. However, such invasive methods are not routinely used.
The use of herbal plant extracts to control weight has also been described. For example, the herb Guarana (Paullinia cupana, P. sorbolis) which contains a high concentration of the active ingredient caffeine has been incorporated into slimming products (Hurel, J.-P., 1993, FR 2 712 191-A1). Caffeine is recognized to have pharmacological activity as a central nervous system stimulant and is a major constituent in many weight-reducing products for its ability to increase metabolic rate. However, use of such a product alone has only a temporary effect, with weight gain seen immediately upon cessation of treatment. Similarly, Prunet (FR 2 687 548 A1) describes the use of Guarana as a nutritional supplement in short term weight reduction. Finally, Primez (Belgium Patent 100593A7) describes a phyto-active mixture referred to as Lycopodium which contains Guarana and other plant extracts including Scillia maritime, Ephedra vulgaris, and Betula alba which may be ingested, applied as a cream or lotion, or injected to produce weight loss. It is suggested that administration of Lycopodium slows gastric draining while improving intestinal transit and evacuation of the intestines. However, no clinical data is provided to support this suggestion.
It has now been found that a combination of selected herbal extracts wherein at least one of the extracts contains caffeine and at least one of the extracts controls gastric emptying is capable of producing weight loss.